A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00231530
First received: September 30, 2005
Last updated: June 6, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to determine the efficacy and safety of topiramate compared with placebo in obese, Type 2 diabetic patients on a controlled diet.


Condition Intervention Phase
Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetic Patients on a Controlled Diet

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The percent change in body weight and change in Hemoglobin A1c from enrollment to Week 60.

Secondary Outcome Measures:
  • Change from enrollment or baseline to Week 60 in BMI, waist circumference, glucose tolerance, lipid profile; safety measures, such as adverse events, throughout study.

Enrollment: 541
Study Start Date: January 2001
Study Completion Date: May 2002
Detailed Description:

Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate in obese, diet-controlled, type 2 diabetic patients. Patients are randomized to receive either topiramate or placebo. After a 5 week pre-enrollment phase followed by a 6 week run-in phase, patients in the topiramate group start an 8-week titration phase to reach the assigned dose of topiramate, either 96 or 192 mg daily. Treatment continues for 1 year. Assessments of effectiveness include percent change in body weight, hemoglobin type A1c [HbA1c] levels, Body Mass Index [BMI], the numbers and proportion of 5% and 10% weight loss responders, glucose tolerance, waist and hip circumferences, changes in the mass of left ventricle of the heart, blood pressures, and fasting lipid profiles. Safety evaluations, including incidence of adverse events, vital signs, clinical laboratory values, and electrocardiograms [ECGs], are monitored throughout the study. The study hypothesis is that topiramate, combined with controlled diet, will be effective in weight reduction and controlling blood sugar level and is well tolerated. During the initial 8 weeks, the oral doses of either a matching placebo or topiramate will be gradually increased to the target doses (96 milligrams[mg] or 192mg daily); the dose will be maintained for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index >= 27 and < 50
  • Diagnosis of Type 2 diabetes according to either Swedish guideline or the American Diabetes Association (ADA) criteria
  • HbA1c <10.5% at enrollment
  • No previous oral antidiabetic medication or insulin therapy
  • Stable body weight
  • Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

  • Known contraindication or hypersensitivity to topiramate
  • Fasting plasma glucose (FPG) >= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, Visit 4 (Week 0)
  • HBA1c of >10.5% at enrollment
  • History of severe recurrent hypoglycemic episodes prior to study entry
  • Use of any systemic corticosteroids within 30 days of enrollment
  • Diagnosed Type 1 diabetes
  • History of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231530

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00231530     History of Changes
Other Study ID Numbers: CR003712
Study First Received: September 30, 2005
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Type 2 Diabetes Mellitus
Obesity
Diabetic Diet
Hypertension
Hyperlipidemia
Adult-Onset Diabetes Mellitus(AODM)

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus
Diabetes Mellitus, Type 2
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on October 16, 2014